A Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease.


To the Editor: In reporting on the Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis (LEVANT) 2 trial, Rosenfield et al. (July 9 issue)1 suggest that angioplasty with a paclitaxel-coated balloon, as compared with angioplasty with a standard balloon, provided superior vessel patency in patients with femoropopliteal disease at 12 months. Although these results are encouraging, it is unclear whether superior vessel patency translates into improvements in more clinically appropriate end points such as ambulatory function and quality of life.2 The majority of the patients in the trial (92%) had moderate intermittent claudication (Rutherford stage 2) or severe intermittent claudication (Rutherford stage 3) (the Rutherford scale ranges from 0 to 6, with higher numbers indicating worse disease), with single, short lesions of the superficial femoral artery. Yet, the primary end point of freedom from binary restenosis or targetlesion revascularization occurred in only 65% of the intervention cohort and 53% of controls. The clinical significance of this difference is unclear, and this lack of clarity highlights the need to design trials that are powered to show the effectiveness of endovascular interventions for the clinical outcomes of femoropopliteal disease, such as improvements in symptoms of claudication.3 In the meantime, enthusiasm for techniques such as this one must be curbed.

DOI: 10.1056/NEJMc1510344

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Cite this paper

@article{Rosenfield2015APB, title={A Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease.}, author={Kenneth A Rosenfield and David Christopher Metzger and Dierk Scheinert}, journal={The New England journal of medicine}, year={2015}, volume={373 18}, pages={1785-6} }